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SUMMARY/JOB PURPOSE:The Director, Analytical Development manages the analytical activities across multiple CMC biologics areas to support...
Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development...
Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing...
Ensure compliance with SEC and Nasdaq rules and requirements, including preparation of SEC reports (Form 10-K, Form 10-Q, Form 8‑K) and other public...
Architect & Deploy AI Solutions:Design scalable solutions using Generative AI (LLMs, multi-modal models) and Agentic AI (multi-agent systems...
* Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing...
* Ensure compliance with SEC and Nasdaq rules and requirements, including preparation of SEC reports (Form 10-K, Form 10-Q, Form 8-K) and other...
* Functional lead on assay strategy, design, and execution of mechanism-of-action and proof-of-concept in vitro pharmacology assays. This...
* Operate in accordance with all Exelixis SOPs, including the Publications SOP, and promote the adoption of working standards consistent with...
* Provide direct legal support to the Commercial-Market Access department, in the furtherance of their operational responsibilities and in...
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